SCIP RHD: Are SubCutaneous Infusions of benzathine Penicillin G (BPG) longer lasting and more acceptable than intramuscular BPG in children with Rheumatic Heart Disease?

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Acute rheumatic fever (ARF) and rheumatic heart disease (RHD) almost exclusively affect Indigenous Maori and Pacific children and young adults living in socio-economically deprived areas of the North Island in Aotearoa, New Zealand. Across the Tasman, the associated morbidity from RHD is the leading driver of cardiovascular inequality for Indigenous Australians. For 70 years, the only proven way to prevent ARF progression has been benzathine penicillin G (BPG), given as a monthly intramuscular (IM) injection. The effectiveness of this approach is limited by pain and the frequency of injection which leads to sub-optimal adherence. There is an urgent need to improve penicillin formulations for all children living with ARF/RHD. Based on previous work we hypothesise that penicillin can be delivered as an ‘implant’ if given as a high-dose subcutaneous (SC) infusion, which will allow for sustained penicillin concentrations (>3 months). This approach would fulfil the ideal product characteristics for the next generation of long acting penicillin. Our Phase I trial showed that SCIP was tolerable and provided sustained penicillin concentrations in healthy adults. We therefore are now moving to Phase II, which will involve children and young adults who are currently receiving monthly BPG injections for their ARF/RHD. Alongside demonstrating safety, tolerability and minimum inhibitory concentrations of Bicillin ®L-A delivered by subcutaneous infusion; we will implement mixed-methods study to identify acceptability, barriers and benefits, both from consumer and health care provider perspectives.